Healthcare solutions provider GE HealthCare (Nasdaq: GEHC) announced on Monday that it has received 510(k) clearance from the U.S. Food and Drug Administration for Photonova Spectra, its next-generation photon-counting CT system. The approval follows the system's debut at the Radiological Society of North America (RSNA) 2025 Annual Meeting.

Photonova Spectra features GE HealthCare's Deep Silicon detector with 8-bin energy resolution, delivering simultaneous ultra-high definition spatial and spectral imaging. The platform supports fast, motion-free scans and precise tissue characterisation across neurology, oncology, musculoskeletal, thoracic and cardiac applications. NVIDIA accelerated computing enables efficient processing of high-volume spectral data, while a one-scan workflow simplifies operations and ensures consistent image quality.

The system is part of GE HealthCare's USD5.1bn innovation programme, expected to drive 1-2% revenue growth. Clinical evaluations are underway at the University of Wisconsin-Madison and Stanford Medicine, exploring advanced imaging protocols, improved tissue contrast and potential new biomarkers.

With FDA clearance, GE HealthCare is preparing for US commercial launch, extending its portfolio of transformational imaging technologies designed to enhance diagnostic precision and workflow efficiency.